BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES

    K Number: K955558 · Decision Feb 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    18
    Review Days
    85

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    Basic Information

    Device Name
    GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES
    K Number
    K955558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medi-Globe Corp.
    Date Received
    December 6, 1995
    Decision Date
    February 29, 1996
    Product Code
    FBK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

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    Other Clearances by Medi-Globe Corp.

    K Number Device Name
    K061222 INJECTRA INJECTION NEEDLE
    K051247 SONOTIP II ULTRASOUND NEEDLE SYSTEM
    K011261 STONE EXTRACTOR BALLOON CATHETER
    K010714 EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
    K010549 BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
    K990220 MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
    K953355 GIP/MEID-GLOBE HOT BIOPSY FORCEPS
    K953827 GIP/MEDI-GLOBE ERCP CATHETERS
    K941973 GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES
    K943935 GIP/MEDI-GLOBE POLYPECTOMY SNARES
    Search all 18 clearances from Medi-Globe Corp. →